Immunomedics Inc. filed a biologics license application with the U.S. Food and Drug Administration, seeking approval for its breast cancer treatment, which is known as sacituzumab govitecan.
The treatment is an antibody-drug conjugate, or ADC, a type of biopharmaceutical drug designed to target cancer cells.
The drug is being evaluated for treating patients who have received at least two prior therapies for triple-negative breast cancer and whose disease has spread to other parts of the body.
Immunomedics said the submission was backed by the results of a phase 1/2 trial. If approved, sacituzumab govitecan would be the first and only ADC approved to treat the disease.
Morris Plains, N.J.-based Immunomedics is focused on developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other diseases.